Prosecution Insights
Last updated: July 17, 2026
Application No. 18/129,468

EMULATING RANDOMIZED CONTROLLED TRIALS USING GENERAL DATA

Non-Final OA §101§112
Filed
Mar 31, 2023
Examiner
KUAN, JOHN CHUNYANG
Art Unit
2857
Tech Center
2800 — Semiconductors & Electrical Systems
Assignee
International Business Machines Corporation
OA Round
3 (Non-Final)
72%
Grant Probability
Favorable
3-4
OA Rounds
0m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 72% — above average
72%
Career Allowance Rate
400 granted / 552 resolved
+4.5% vs TC avg
Strong +47% interview lift
Without
With
+47.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 0m
Avg Prosecution
40 currently pending
Career history
582
Total Applications
across all art units

Statute-Specific Performance

§101
23.4%
-16.6% vs TC avg
§103
56.7%
+16.7% vs TC avg
§102
4.7%
-35.3% vs TC avg
§112
14.1%
-25.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 552 resolved cases

Office Action

§101 §112
DETAILED ACTION Notice of Pre-AIA or AIA Status The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Continued Examination Under 37 CFR 1.114 A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/20/2026 has been entered. Claim Objections Claims 5-7, 17, and 20 are objected to because of the following informalities: In claim 5, line 8, “the subject data” should be --the subject medical treatment data-- to be consistent with its antecedent basis. In claim 6, line 2, “the subject data” should be --the subject medical treatment data-- to be consistent with its antecedent basis. In claim 7, line 2, “the subject data” should be --the subject medical treatment data-- to be consistent with its antecedent basis. In claim 17, line 8, “the subject data” should be --the subject medical treatment data-- to be consistent with its antecedent basis. In claim 20, line 8, “the subject data” should be --the subject medical treatment data-- to be consistent with its antecedent basis. Appropriate correction is required. Claim Rejections - 35 USC § 112 The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Regarding claim 1, it recites “providing to an end user a recommendation with respect to the same treatment based on the determined outcome of the same treatment” in the end. This is not supported by the written description. Specification [0041] discloses “provide a recommendation to an end user”; and [0042] discloses “provide a recommendation based on historical data.” Nowhere does the specification disclose the above indicated limitation at issue. For examples, there is no disclosure about what is recommended based on the outcome of the same treatment; and how the recommendation is made based on the outcome of the same treatment. One skilled in the relevant art will not be reasonably conveyed that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 15 and 18 are rejected by analogy to claim 1. The other claim(s) not discussed above, or depending on the above claim(s), are rejected for inheriting the issue(s) from their linking claim(s). Notes Claim 1, 15, and 18 distinguish over the closest prior as discussed below. Regarding claim 1, 15 and 18, the closest prior art of record fails to teach the features of claim 1 (as the representative): “determining, by a processor set, for each of a plurality of covariates in subject medical treatment data on a plurality of subjects, a statistical bias measure; selecting, by the processor set, one of the plurality of covariates based on the statistical bias measure; dividing, by the processor set, the plurality of subjects into two or more groups, based on the selected covariate, such that each of the two or more groups has an enhanced uniformity in a probability of being assigned a same treatment in a hypothetical randomized controlled trial; recursively repeating, by the processor set, for each respective group of the two or more groups, the dividing the plurality of subjects into the two or more groups, until reaching a selected stopping criterion for the respective group; deriving, by the processor set, observational results of one or more input factors of one or more of the groups resulting from the dividing; constructing, by the processor set, a causal tree having a plurality of leaves using the derived observational results, each of the plurality of leaves emulating a separate independent randomized control trial from which valid causal inference and associated treatment propensity based on the subject medical treatment data are estimated,” in combination with the rest of the claim limitations as claimed and defined by the Applicant. Response to Arguments The objections to the claims have been fully considered. However, there are new informalities found, as indicated in the objections above. Regarding 35 USC 101, Applicant’s arguments, see Remarks at pp. 8-11, filed 02/20/2026, have been fully considered and are persuasive. The rejections of claims 1-20 regarding under 35 USC 101 have been withdrawn. The Examiner notes that the amended claims are narrowly tailored to specific steps of processing subject medical treatment data to determine an outcome of a treatment in a hypothetical randomized controlled trial on a plurality of subjects. As disclosed in the specification, randomized controlled trials are costly and time-consuming (see specification [0003]). The evidence on the record show that the amended claims are directed to a technical improvement in obtaining an outcome of a randomized controlled trial from existing subject medical treatment data, without the need of conducting onerous and expensive actual randomized controlled trials. This saves time and costs of developing new medical treatments (see specification [0021]). Therefore, the amended claims are direct to a technical improvement, and not an abstract idea, according to the USPTO Memorandum dated 12/05/2025 (“Advance notice of change to the MPEP in light of Ex Parte Desjardins”). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN C KUAN whose telephone number is (571)270-7066. The examiner can normally be reached M-F: 9:00AM-5:30PM. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Schechter can be reached at (571) 272-2302. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /JOHN C KUAN/Primary Examiner, Art Unit 2857
Read full office action

Prosecution Timeline

Show 7 earlier events
Jan 29, 2026
Applicant Interview (Telephonic)
Feb 20, 2026
Response after Non-Final Action
Mar 30, 2026
Request for Continued Examination
Apr 06, 2026
Response after Non-Final Action
Apr 29, 2026
Non-Final Rejection mailed — §101, §112
Jun 18, 2026
Interview Requested
Jun 30, 2026
Examiner Interview Summary
Jun 30, 2026
Applicant Interview (Telephonic)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

3-4
Expected OA Rounds
72%
Grant Probability
99%
With Interview (+47.0%)
3y 0m (~0m remaining)
Median Time to Grant
High
PTA Risk
Based on 552 resolved cases by this examiner. Grant probability derived from career allowance rate.

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